Sun Protection of Kidney Transplant Recipients

Not Applicable

Completed

• Conditions: Unspecified Complication of Kidney Transplant; Disorder Related to Renal Transplantation
• Interventions: Behavioral: Internet-based sun protection education

• Registration Number: NCT01646099
• Lead Sponsor: Northwestern University

Brief Summary

This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.

Detailed Description

Cognitive interviews about an internet-based sun protection strategies program will be performed with up to 45 kidney transplant recipients (KTRs) who have participated in past surveys. A second group of 150 KTRs will be asked to evaluate the internet-based module for the effectiveness of information. A third group of 12 KTRs will be asked to evaluate the internet-based module for usability. A fourth group of 160 KTRs will be asked to take part in a randomized controlled trial evaluating the fully developed internet-based sun protection strategies program.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients. (National Kidney Foundation 2006) The NKF supported standard, formal, well timed skin cancer prevention information and sending reminders to KTRs at the beginning of summer.

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photoprotective pigment in the skin.

2. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.

3. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.

Study Timeline

• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Study Start: 2013-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Subjects with a history of kidney transplantation within the last 5 years
• Speaks English
• Can see to read
• Lives in the greater Chicago area and can attend a cognitive interview session
• 18-85 years old

Read More

Exclusion Criteria

• Unable to speak English
• Cognitive impairment or neurologic disease
• Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level
• Has had a skin cancer

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sun Protection Education	Internet-based sun protection education	Distribution of the internet-based sun protection educational program.

Primary Outcome Measures

Name	Time	Method
Use of sun protection	6 weeks	Use of sun protection will be measured using 10 questions about what a person regularly does in summer during a warm sunny day and during a cloudy day regarding: 1) use of sunscreen; 2) wearing hat; 3) shirt with sleeves; 4) sunglasses; and 5) staying in the shade. The scores for these questions will be summed to derive a dichotomous measure of sun protection use (1= use of sun protection often or always; 0 otherwise).

Secondary Outcome Measures

Name	Time	Method
Forearm skin pigment	6 weeks	Skin pigment as measured by reflectance spectrophotometry, ranging from limited \[225 area-under-the-curve (AUIC)\] to dense (75 AUIC).
Level of sun burn or skin irritation from the sun	6 weeks	Three telephone interviews will be done on Mondays after at least 2 holiday weekends in which the weather is reported as sunny or partly sunny by the national weather service (Memorial Day, 4th of July and Labor Day) as well as one sunny non-holiday weekend. The KTR will be asked if they experienced a sunburn or skin irritation. The response will be dichotomous (yes/no).

Trial Locations

Locations (1)

Northwestern Memorial Faculty Foundation; 🇺🇸 Chicago, Illinois, United States